Devices, systems, and methods for repairing soft tissue and attaching soft tissue to bone

ABSTRACT

Devices, systems and/or methods for fixating soft tissue to bone are provided. In one embodiment, a repair device for fixating soft tissue to bone with a bone anchor includes a soft tissue anchor and one or more flexible members. The soft tissue anchor includes a base with multiple legs extending from the base. The one or more flexible members are coupled to the base and configured to extend from the base to the bone anchor with a fixed length. With this arrangement, the fixed length of the one or more flexible members is configured to maintain a substantially fixed pre-determined distance between the soft tissue anchor and the bone anchor such that, as the bone anchor is seated into bone, the one or more flexible members pulls the soft tissue anchor down against the soft tissue to fixate the soft tissue to the bone.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a divisional of U.S. patent application Ser. No. 16/279,337, filed Feb. 19, 2019, which clams the benefit of U.S. Provisional Application No. 62/633,000, filed Feb. 20, 2018, the disclosures of which are hereby incorporated herein by reference in their entirety. Further, U.S. patent application Ser. No. 16/279,337 also claims the benefit, and is a continuation-in-part of, U.S. patent application Ser. No. 16/226,573, filed Dec. 19, 2018, which claims benefit of U.S. Provisional Application No. 62/608,533, filed Dec. 20, 2017, and U.S. Provisional Application No. 62/633,000, filed Feb. 20, 2018, the disclosures of which are hereby incorporated herein by reference in their entirety.

TECHNICAL FIELD

The present invention relates generally to soft tissue repair sites. More particularly, the present invention relates to devices, systems, and methods for repairing soft tissue and attaching soft tissue to bone.

BACKGROUND

One of the most common needs in orthopedic surgery is the fixation of soft tissue, such as ligament or tendon, to bone. Typically, fixating soft tissue to bone is implemented with a bone anchor and suture material with suture coupled between the soft tissue and the bone anchor such that the soft tissue is cinched in against the bone. However, coupling suture to soft tissue is time consuming and often requires complex suture patterns for effective fixation, often requiring specialized surgeons. While this can provide a good initial repair, the strength and quality of the repair may quickly degrade with subsequent loading and mobilization, often resulting is subsequent procedures depending on the activity level of the patient. As such, it would be advantageous to eliminate the complexity and the time consuming nature of this type of surgery while also increasing the long term effectiveness of the procedure.

BRIEF SUMMARY OF THE INVENTION

Embodiments of the present invention are directed to various devices, systems and methods for repairing soft tissue and attaching soft tissue to bone at a soft tissue repair site. For example, in one embodiment, a repair device system for fixating soft tissue to bone is provided. The repair device system includes a bone anchor, a soft tissue anchor, and one or more flexible members. The bone anchor includes an elongated structure extending between a proximal end and a distal end, the bone anchor defining a bone anchor axis extending along the elongated structure. The soft tissue anchor includes a base with multiple legs extending from the base so as to extend toward the bone anchor. The one or more flexible members extend to couple the soft tissue anchor to the bone anchor. Further, the one or more flexible members are sized and configured to substantially maintain the soft tissue anchor to be spaced relative to the bone anchor at a pre-determined distance.

In another embodiment, as the bone anchor is seated into bone, the one or more flexible members facilitate the soft tissue anchor to simultaneously fixate the soft tissue against the bone. In another embodiment, the base defines a central opening extending centrally through the base, the soft tissue anchor defining a tissue anchor axis extending axially relative to the central opening of the base, the tissue anchor axis configured to extend substantially co-axial with the bone anchor axis. In another embodiment, the base of the anchor extends with an upper surface and an underside surface to define an outer periphery therebetween, the legs extending directly from the outer periphery and extending with a bend so that the legs are configured to extend toward the bone anchor. In another embodiment, the one or more flexible members extends with a continuous loop. In still another embodiment, the one or more flexible members include two loop portions extending upward from the bone anchor to wrap around portions of the soft tissue anchor.

In another embodiment, the one or more flexible members include one or more flexible filaments extending in a woven configuration. In another embodiment, the one or more flexible members is configured to couple to at least one of a notch, a recess and a through hole defined in the elongated structure of the bone anchor.

In accordance with another embodiment of the present invention, a medical device system for fixating soft tissue to bone is provided. The medical device system includes a delivery instrument and a repair device system. The delivery instrument includes an elongated portion defining a delivery instrument axis and includes a distal impacting surface. The repair device system is configured to be removably coupled to the delivery instrument. The repair device system includes a bone anchor, a soft tissue anchor, and one or more flexible members. The bone anchor includes an elongated structure extending between a proximal end and a distal end, the bone anchor defining a bone anchor axis extending along the elongated structure. The soft tissue anchor includes a base with multiple legs extending from the base, the base defining a central opening defining a tissue anchor axis. The one or more flexible members extend to couple the soft tissue anchor to the bone anchor. With this arrangement, the repair device system is removably coupled to the delivery instrument with the elongated portion extending through the central opening of the soft tissue anchor and the distal impacting surface abutted against the proximal end of the bone anchor such that, as the bone anchor is being implanted into bone, the one or more flexible members extend taut between the bone anchor and the soft tissue anchor to simultaneously pull the soft tissue anchor into the soft tissue.

In another embodiment, the repair device system is configured to be delivered with the delivery instrument such that the delivery instrument axis is substantially coaxial, or substantially parallel, with the bone anchor axis and the tissue anchor axis. In another embodiment, as the bone anchor is seated into bone with the delivery instrument, the one or more flexible members maintain a substantially fixed distance between the bone anchor and the soft tissue anchor. In another embodiment, as the bone anchor is seated into bone with the delivery instrument, the soft tissue anchor compresses soft tissue against the bone with the one or more flexible members coupled to the soft tissue anchor. In still another embodiment, the one or more flexible members are a fixed length such that, upon the one or more flexible members being in a taut position, the one or more flexible members maintain a substantially fixed distance between the bone anchor and the soft tissue anchor in a pre-delivered state and a delivered state. In another embodiment, the bone anchor defines a hole in the proximal end of the bone anchor, the hole sized and configured to receive an alignment portion extending from adjacent the distal impacting surface of the delivery instrument.

In another embodiment, the medical device system further includes a retainer element, the retainer element having a line and a retaining portion, the line extending along an underside of the soft tissue anchor and toward the retaining portion, the retaining portion being removably coupled to the delivery instrument and configured to retain the line thereto. In another embodiment, the medical device system further includes a retainer element sized and configured to removably couple the delivery instrument to the repair device system, the retainer element having a line configured to be positioned along an underside of the soft tissue anchor to position the one or more flexible members in a taut position.

In accordance with another embodiment of the present invention, a method of fixating soft tissue to bone is provided. The method includes the steps of: providing a bone anchor coupled to a soft tissue anchor with one or more flexible members such that the bone anchor is engaged with a distal impacting surface of a delivery instrument with the soft tissue anchor positioned proximally along the delivery instrument with the one or more flexible members extending along the delivery instrument between the bone anchor and soft tissue anchor; positioning a distal end of the bone anchor adjacent the soft tissue and adjacent a pre-formed hole defined in the bone with the soft tissue positioned over the bone; and applying a force to the bone anchor with the delivery instrument to drive the bone anchor through the soft tissue and into the pre-formed hole such that, upon the bone anchor being driven into the pre-formed hole, the one or more flexible members pull legs extending from a base of the soft tissue anchor into the soft tissue such that an underside of the base is positioned against an outer surface of the soft tissue to substantially fixate the soft tissue against the bone.

In another embodiment, the step of applying includes driving the bone anchor into the pre-formed hole to substantially simultaneously couple the soft tissue anchor to the soft tissue. In another embodiment, the step of applying includes pulling the legs of the soft tissue anchor into the soft tissue with the one or more flexible members coupled to the bone anchor so that the soft tissue anchor clamps down upon the soft tissue as the bone anchor is seated within the pre-formed hole. In another embodiment, the step of applying includes maintaining a substantially fixed distance between the bone anchor and the soft tissue anchor with the one or more flexible members. In still another embodiment, the step of applying includes pounding a proximal end of the delivery instrument so that the distal impacting surface of the delivery instrument pounds the bone anchor into the pre-formed hole of the bone. In yet another embodiment, the step of providing includes providing a retainer element for removably coupling the bone anchor to the delivery instrument, the retainer element having a line extending along an underside of the soft tissue anchor so that the one or more flexible members maintain a taut position.

In accordance with another embodiment of the present invention, a repair device for fixating soft tissue to bone with a bone anchor is provided. The repair device includes a soft tissue anchor and one or more flexible members. The soft tissue anchor includes a base with multiple legs extending from the base. The one or more flexible members are coupled to the base and configured to extend from the base to the bone anchor with a fixed length.

In another embodiment, the base includes coupling structure configured to couple the one or more flexible members thereto, the coupling structure including at least one of a protrusion, an opening, and a notch. In another embodiment, the one or more flexible members include one or more flexible filaments extending in a woven configuration. In still another embodiment, the one or more flexible members include a continuous loop. In yet another embodiment, the one or more flexible members include one or more sutures. In another embodiment, the one or more flexible members extend along the base and through the central opening of the soft tissue anchor with a descending loop portion of the one or more flexible members.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

The foregoing and other advantages of the invention will become apparent upon reading the following detailed description and upon reference to the drawings in which:

FIG. 1 is a perspective exploded view of a medical device system, depicting a repair device system and a delivery instrument, according to one embodiment of the present invention;

FIG. 2 is a perspective view of a soft tissue anchor, according to another embodiment of the present invention;

FIG. 2A is a top view of the soft tissue anchor of FIG. 2, depicting the soft tissue anchor as cut from sheet material, according to another embodiment of the present invention;

FIG. 2B is a top view of a soft tissue anchor, depicting another embodiment of the soft tissue anchor as cut from sheet material, according to the present invention;

FIG. 3 is a perspective view of the repair device system of FIG. 1, depicting a bone anchor coupled to the soft tissue anchor with one or more flexible members, according to another embodiment of the present invention;

FIG. 3A is a perspective view of the soft tissue anchor, depicting another embodiment of the one or more flexible members coupled to the soft tissue anchor, according to the present invention;

FIG. 4 is a partial perspective view of the medical device system of FIG. 1, depicting the medical device system in assembled form prior to delivery of the repair device system, according to another embodiment of the present invention;

FIG. 5 is a side view of the medical device system, depicting the system prior to being delivered to a pre-formed hole in bone and fixating soft tissue to the bone, according to another embodiment of the present invention;

FIG. 6 is a side view of the repair device system, depicting the bone anchor implanted in bone and the soft tissue anchor holding the soft tissue against the bone in a fixated manner, according to another embodiment of the present invention;

FIG. 7 is a perspective view of another embodiment of a repair device system, depicting one flexible member with the soft tissue anchor and the flexible member being coupled to an intermediate portion of the bone anchor, according to the present invention;

FIG. 8 is a perspective view of another embodiment of a repair device system, according to the present invention;

FIG. 9 is a perspective view of a soft tissue anchor of the repair device system of FIG. 8, according to another embodiment of the present invention;

FIG. 10 is a perspective view of a bone anchor of the repair device system of FIG. 8, according to another embodiment of the present invention;

FIG. 11 is a top view of the bone anchor of FIG. 10, according to another embodiment of the present invention;

FIG. 11A is a cross-sectional view of the bone anchor taken along section line A-A of FIG. 11, according to another embodiment of the present invention;

FIG. 11B is a cross-sectional view of the bone anchor taken along section line B-B of FIG. 11, according to another embodiment of the present invention;

FIG. 12 is a perspective view of another embodiment of a medical device system, depicting a delivery instrument and the repair device system of FIG. 8, according to the present invention;

FIG. 13 is an enlarged view of the medical device system of FIG. 12, according to another embodiment of the present invention; and

FIG. 13A is a cross-sectional view of the medical device system taken along section line A-A of FIG. 13, depicting a retainer element for holding the repair device system to the delivery instrument, according to another embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Various embodiments are disclosed herein of a soft tissue repair device and system. Such repair device and system may be sized and configured to approximate and fuse, for example, soft tissue to bone. The various embodiments may provide structure that maintains the soft tissue against bone in an abutting relationship, without gapping. In this manner, the repair device and system of the present invention may provide the proper healing required for fusing the soft tissue to bone.

With reference to FIG. 1, one embodiment of a medical device system 10, shown in an exploded state, is provided. Such medical device system 10 may be employed to fixate soft tissue, such as tendon and ligament, to bone. The medical device system 10 may include a delivery instrument 12 and a repair device system 14, the delivery instrument 12 designed to facilitate anchoring a repair device or repair device system 14 to soft tissue and to bone. The repair device system 14 may include a soft tissue anchor 16 configured to be associated with or coupled to a bone anchor 18. In one embodiment, the soft tissue anchor 16 may be coupled to the bone anchor 18 with one or more flexible members 20. Upon assembling the medical device system 10, the repair device system 14 may be sized and configured to fixate soft tissue to bone such that, as the bone anchor 18 is being seated and anchored into bone, the soft tissue anchor 16 may be simultaneously seated and anchored to soft tissue (see FIGS. 5-6).

Now with reference to FIGS. 2 and 2A, the soft tissue anchor 16 will now be described. As set forth, the soft tissue anchor 16 may be sized and configured to sink into soft tissue and be coupled thereto. The soft tissue anchor 16 may include a base 22 and multiple legs 24 extending from the base 22. The soft tissue anchor 16 may be formed from sheet material so that the anchor 16, including the base 22 and the multiple legs 24, may be formed as a seamless, monolithic and one-piece structure, as depicted in FIG. 2A. The soft tissue anchor 16 may be formed from a metallic material, such as stainless steel, titanium, or Nitinol, or any other suitable medical grade material or combinations of materials. Such metallic material may be laser cut from the sheet material or cut using any suitable technique known in the art. In another embodiment, the soft tissue anchor 16 may be formed from a polymeric material or a bioresorbable material. Upon being cut from the sheet material, the legs may be bent to position the legs downward or moved to orient the legs to extend away from a single side or underside of the anchor 16, as depicted in FIG. 2. Once the legs 30 have been appropriately oriented and bent into position, the anchor may then be electro polished or chemically polished, as desired. In another embodiment, the soft tissue anchor 16 may be formed from a medical grade polymeric material, as known to one of ordinary skill in the art. In another embodiment, the soft tissue anchor 16 may be formed from a bioresorbable material, as known to one of ordinary skill in the art. In another embodiment, as depicted in FIG. 2B, a soft tissue anchor 26 may include a base 28 with legs 30 extending therefrom such that the legs 30 may be formed with a barb 32 or multiple barbs extending therefrom. Such soft tissue anchor 26 may be formed in a similar manner as the soft tissue anchor described and depicted relative to FIGS. 2 and 2A herein and may be employed with the medical device system 10 (FIG. 1) as described and depicted herein.

With reference to FIG. 2, the base 22 of the soft tissue anchor 16 may be flat and generally include a thickness 34 of the before-discussed sheet material. The base 22 may extend in a generally circular configuration with a central opening 36 defined therein so as to define a flat ring like structure or the like. With such central opening 36, the base 22 may define an upper surface 38 and an underside surface 40 each extending to an inner periphery 42 and an outer periphery 44 of the base 22. The central opening 36 may be centered axially so as to define a tissue anchor axis 46 (see also FIG. 2A) extending perpendicular relative to the upper surface 38 and underside surface 40 of the base 22. Further, the upper surface 38 and the underside surface 40 may extend, for the most part, in a planar manner such that the base 22 extends as a flat structure. In another embodiment, the upper surface 38 and/or the underside surface 40 may be formed with a dome configuration.

In one embodiment, the anchor 16 may include coupling structure 48 sized and configured to couple the one or more flexible members 20 thereto. Such coupling structure 48 may be formed on or in the base 22 so as to be associated with the outer periphery 44 or the inner periphery 42 or both. For example, the base 22 may include the coupling structure 48 that may be in the form of multiple extensions or protrusions 50 extending outward from the base 22 so as to expand the surface area of the upper surface 38 and underside surface 40 of the base 22. Further, for example, the outer periphery 44 may include three protrusions 50 such that each protrusion may extend along the outer periphery 44 between separate pairs of the multiple legs 24. In another embodiment, the coupling structure 48 may be in the form of notches or recesses formed in the outer periphery or through holes extending between the upper surface 38 and the underside surface 40 of the base 22. In another embodiment, the coupling structure 48, similar to that described, may extend from or be defined in the inner periphery 42 of the base 22. In another embodiment, the above-described coupling structure 48 may extend from or be defined in both the inner and outer peripheries 42, 44 of the base 22 or the like. In still another embodiment, one or more of the legs 24 may act, at least in part, as the coupling structure 48 for coupling the one or more flexible members 20.

As previously set forth, the soft tissue anchor 16 may include the multiple legs 24 that may extend from the base 22. For example, the soft tissue anchor 16 may include six legs or more or less legs. In some applications, it may only be necessary for the soft tissue anchor 16 to include three, four, or five legs. In other applications where the holding strength needs to be greater, the soft tissue anchor 16 may include seven or eight legs. In another embodiment, the multiple legs 24 may extend from the outer periphery 44 so as to bend downward. In one embodiment, the multiple legs 24 may extend in a common direction. In another embodiment, the legs 24 may extend downward so as to be oriented to extend generally from the underside surface 40 of the base 22. In another embodiment, the legs 24 may extend substantially perpendicular relative to the underside surface 40 and substantially parallel relative to the tissue anchor axis 46. In another embodiment, each of the legs 24 may extend from the base 22 with a curvature 52 or a radius from the outer periphery 44 to then extend generally linear to a free end 54. With such curvature 52 or radius, the legs 24 may extend downward relative to the base 22 such that the free end 54 of the legs 24 may be positioned with a radial distance 56 relative to the tissue anchor axis 46 that may be larger than a radial distance 58 of the outer periphery 44 relative to the tissue anchor axis 46. Some portions of the outer periphery 44, such as ends of the protrusions 50, may extend further radially or include a similar radial distance relative to the tissue anchor axis 46 as the radial distance 56 of the legs 24 or free ends 54 of the legs. Further, the free end 54 of each leg 24 may extend with a free edge 60 such that an end portion of each leg may extend with a tapered portion 62 sized and configured to taper to the free end 54. Such free edge 60 may be defined by the thickness 34 of the sheet material and may be pointed so as to facilitate the legs 24 of the anchor 16 to readily penetrate soft tissue.

Now with reference to FIG. 3, the repair device system 14, in an assembled state, and the components thereof will now be described. As previously set forth, the repair device system 14 may include the soft tissue anchor 16 associated with or coupled to the bone anchor 18. The bone anchor 18 may be sized and configured to be permanently seated within a pre-formed hole (not shown). The bone anchor 18 may be formed of a polymeric material, such as PEEK (polyether ether ketone), or any other suitable polymeric material. In another embodiment, the bone anchor 18 may be formed of a metallic material, such as titanium, or any other suitable metallic material or combination of metallic materials, such as stainless steel. In still another embodiment, the bone anchor 18 may be formed of a bioresorbable material, such as PLGA (polylactic-co-glycolic acid), or any other suitable bioresorbable material. Further, such bone anchor 18 may be formed using typical manufacturing processes, as known to one of ordinary skill in the art.

In one embodiment, the bone anchor 18 may be an elongated structure 70 to define a bone anchor axis 72, the bone anchor axis 72 extending axially and centrally relative to the elongated structure 70. The elongated structure 70 of the bone anchor 18 may extend between a proximal end 74 and a distal end 76. In one embodiment, the bone anchor 18 may be sized and configured with structure to couple to the before-described soft tissue anchor 16. In another embodiment, the bone anchor 18 may include bone coupling structure 78 sized and configured to couple to bone. For example, the bone coupling structure 78 may include multiple ribs 80 along an outer surface 82 of the bone anchor 18. The multiple ribs 80 may extend laterally relative to the elongated structure 70 of the bone anchor 18. Each of the multiple ribs 80 may extend continuously around the outer surface 82 of the bone anchor 18 such that the ribs 80 may each exhibit a laterally extending arcuate structure. Further, each of the multiple ribs 80 may be evenly spaced relative to each other. Further, each rib 80 may each extend to define a proximal rib shelf 84 and a descending tapering side wall 86, tapering downward from the proximal rib shelf 84, such that the side wall 86 may extend downward to the proximal rib shelf 84 of a distal rib. In another embodiment, the bone coupling structure 78 may include winding threads extending along the outer surface 82 of the bone anchor 18.

The proximal end 74 of the bone anchor 18 may include a proximal end surface 88 that may define a generally circular profile. Further, the proximal end surface 88 may define a proximal end hole 90 or recess that may receive an engaging structure 142 (FIG. 1) of the delivery instrument 12, discussed further herein. Such proximal end hole 90 may be centrally aligned along the bone anchor axis 72 and within the proximal end surface 88. Further, the proximal end hole 90 may be defined with a downward or distally extending side wall 92 or side walls. In one embodiment, the distally extending side wall 92 may slightly taper inward toward the bone anchor axis 72 so as to facilitate an interference fit of the engaging structure 142 (FIG. 1) of delivery instrument 12 sized and configured to be inserted in the proximal end hole 90. In another embodiment, the engaging structure 142 may slightly taper toward a distal end 122 of the delivery instrument 12 (see FIG. 1).

The distal end 76 or distal end portion of the bone anchor 18 may define a notch 94 or recess therein. Such notch 94 may be sized and configured to receive a portion of one of the one or more flexible members 20. The notch 94 may be an opening extending as a channel in the distal end 76 of the bone anchor 18 such that the notch 94 may extend within the distal end portion of the bone anchor 18 so that a portion of the notch 94 extends through opposing sides 96 of the distal end portion of the bone anchor 18. In this manner, the notch 94 adjacent the distal end 76 of the bone anchor 18 may receive one of the one or more flexible members 20 to then be pulled deeper within the notch 94 so that the flexible member 20 may extend through and from the opposing sides 96 of the notch 94 adjacent the distal end portion of the bone anchor 18.

As previously set forth, the soft tissue anchor 16 may be coupled to the bone anchor 18 with the one or more flexible members 20. The one or more flexible members 20 may be formed from one or more polymeric filaments or fibers. The polymeric filaments or fibers may be a polyethylene material, such as ultra-high-molecular-weight polyethylene (“UHMWPE”), a polyester material, a polypropylene material, or the like. In another embodiment, the one or more flexible members 20 may be formed of suture material. In another embodiment, the polymeric filament or fiber may be a bioresorbable material, such as polylactide (“PLA”), polycaprolactone (“PCL”), polydioxanone (“PDX”), or the like, or any other suitable bioresorbable material as known to one of ordinary skill in the art. In another embodiment, the filaments or fibers may be formed in a woven or braided configuration or may extend with strands wound in a side-by-side configuration, or may extend with strands wound side-by-side and in a twisted configuration or any other suitable configuration to form a flexible member.

In one embodiment, the one or more flexible members 20 may include a first flexible member 98 and a second flexible member 100. The first flexible member 98 may extend with a continuous loop. The continuous loop of the first flexible member may be sized and configured to extend around the coupling structure 48 of the base 22, such as the protrusions 50, so that the continuous loop wraps around the base 22 of the soft tissue anchor 16. The continuous loop of the first flexible member 98 may extend with filaments in a braided or woven configuration. In another embodiment, the first flexible member may be a flexible wrap made of one or more flexible filaments that may be wound around the coupling structure 48 of the base 22, such as the protrusions 50, such that the one or more flexible filaments may be wound with multiple windings.

The second flexible member 100 may extend with a continuous loop. In another embodiment, the second flexible member 100 may extend with a loop with two free ends. In another embodiment, the second flexible member 100 may be a suture or the like. The second flexible member 100 may extend to wrap around and couple to the first flexible member 98 adjacent the base 22 of the soft tissue anchor 16. Further, the second flexible member 100 may couple to the first flexible member 98 at multiple locations, such as three locations along the first flexible member 98. For example, the second flexible member 100 may wrap over and couple to mid-portions 102 between connection points 104 of the first flexible member 98 and the protrusions 50 of the base 22 such that the second flexible member 100 may pull the mid-portions 102 inward relative to the base 22 and over the central opening 36 adjacent the inner periphery 42 of the base 22. From the mid-portions 102 of the first flexible member 98, the second flexible member 100 may extend downward through the central opening 36 of the soft tissue anchor 16 with a descending flexible member portion that may be in the form of a descending loop portion 106. The descending loop portion 106 may include a lower loop portion 108 that may be coupled to the bone anchor 18. In one embodiment, the lower loop portion 108 of the descending loop portion 106 may be inserted into the notch 94 defined in the bone anchor 18 to couple the soft tissue anchor 16 to the bone anchor 18, as previously described. The descending loop portion 106, descending from the first flexible member 98, may extend downward with a predetermined length 110 so that the bone anchor 18 may be positioned a predetermined distance from the soft tissue anchor 16. In this manner, the repair device system 14 may be assembled with the one or more flexible members 20, such as the first and second flexible members 98, 100, coupling the soft tissue anchor 16 to the bone anchor 18. Further, in this manner, the soft tissue anchor 16 may maintain a substantially fixed distance from the bone anchor 18 upon the one or more flexible members 20 being pulled taut. Further, the soft tissue anchor 16 may be coupled to the bone anchor 18 with the one or more flexible members 20 such that the tissue anchor axis 46 and the bone anchor axis 72 may be substantially coaxial or substantially parallel relative to each other.

With respect to FIG. 3A, another embodiment of a second flexible member 112 extending in continuous loop form is provided. In this embodiment, the second flexible member 112 may be coupled to the first flexible member 98 and to the soft tissue anchor 16 in a similar manner previously described. The second flexible member 112 in this embodiment may loop around the mid-portions 102 of the first flexible member 98 such that the continuous loop may be passed through itself at one loop end portion 114 to then extend downward with a descending loop portion 116 which may be sized and configured to couple to the bone anchor 18 (FIG. 3), similar to that previously described.

With the repair device system 14 assembled, as depicted in FIG. 3, the assembled repair device system may be assembled with the delivery instrument 12, as depicted in FIG. 4. Now with reference to FIGS. 1, 3, 4 and 5, the delivery instrument 12 and assembly with the repair device system 14 will now be described.

The delivery instrument 12 may be an elongated structure extending between a proximal end 120 and a distal end 122 with a longitudinal length 124. The delivery instrument 12 may define a delivery instrument axis 126 extending centrally along the length 124 of the delivery instrument 12. The proximal end 120 may define a proximal impact surface 128 positioned proximally of a handle 130. The delivery instrument 12 may also include an impact shaft 132 coupled to the handle 130 and extending longitudinally and distally from the handle 130 along the delivery instrument axis 126. Further, the delivery instrument 12 may include a distal end portion 134, the distal end portion 134 including a clipping portion 136, an alignment portion 138, a distal impact surface 140, and engaging structure 142. The clipping portion 136 may be coupled to a distal portion of the impact shaft 132 and may include one or more clips 144 for suspending the soft tissue anchor 16 adjacent a distal underside of the clipping portion 136. The alignment portion 138 may extend distally of the clipping portion 136 with a cylindrical structure and may be a continuous extension of the impact shaft 132. The engaging structure 142 may extend distally of the alignment portion 138 and, more specifically, may extend from and distal of the distal impact surface 140. The distal impact surface 140 may be defined as a shelf 146 extending laterally from the engaging structure 142 and may extend substantially perpendicular relative to the delivery instrument axis 126. The engaging structure 142 may be cylindrical or the like and may be sized and configured to mate and correspond with the proximal end hole 90 of the bone anchor 18 so that the distal impact surface 140 abuts against the proximal end surface 88 of the bone anchor 18. With this arrangement, the distal end portion 134 of the delivery instrument 12 may be removably coupled to the repair device system 14, as described below.

With the repair device system 14 assembled, the alignment portion 138 of the delivery instrument 12 may be inserted through the central opening 36 of the soft tissue anchor 16 to then position the engaging structure 142 into the proximal end hole 90 of the bone anchor 18. The one or more clips 144 may be positioned along the underside surface of the base 22 of the soft tissue anchor 16 to suspend the soft tissue anchor 16 below an underside of the clipping portion 136. In this position, the one or more flexible members 20 including the descending loop portion 106 may be placed in a somewhat taut orientation or position. With the repair device system 14 coupled to the distal end portion 134 of the delivery instrument 12, each of tissue anchor axis 46, the bone anchor axis 72 and the delivery instrument axis 126 may be coaxial or substantially coaxial relative to each other. Further, with this arrangement, the repair device system 14 may be removably coupled to the distal end portion 134 of the delivery instrument 12 and may be employed to fixate soft tissue 5 to bone 7.

Now with reference to FIGS. 5 and 6, an embodiment for delivering the repair device system 14 with the delivery instrument 12 will now be described. In preparation to deliver the repair device system 14, a physician may form a hole 9 in the bone 7 adjacent to the location desired for fixating the soft tissue 5. Such hole 9 in the bone 7 may be prepared with a suitably sized awl (not shown) or the like, as known to one of ordinary skill in the art. The depth of the hole 9 may be deeper than a height or elongated length of the bone anchor 18 and should be sized and configured to receive the bone anchor 18 with an interference fit such that the ribs 80 of the bone anchor 18 stabilize and appropriately seat the bone anchor 18 in the bone 7. Once an appropriate hole 9 has been pre-formed in the bone 7, the physician may position a portion of the soft tissue 5 desired for fixating to the bone 7 to a position over the pre-formed hole 9 in the bone 7. The physician may then form a thin slit (not shown), such as with a scalpel, within the soft tissue 5 directly above the pre-formed hole 9 in the bone 7. The distal end 76 of the bone anchor 18, being assembled with the delivery instrument 12, may then be positioned and inserted through the slit in the soft tissue 5 so that the distal end 76 is positioned within a top portion 13 of the pre-formed hole 9 in the bone 7. The physician may then orient the delivery instrument 12 so that the delivery instrument 12 may be substantially aligned and coaxial with a central axis 11 of the pre-formed hole 9. At this juncture, the physician may employ an impacting instrument, such as a hammer (not shown), to impact the proximal impact surface 128 of the delivery instrument 12. The impact force of the hammer directly translates to an impact force placed upon the proximal end surface 88 of the bone anchor 18 abutted with the distal impact surface 140 of the delivery instrument 12 (see FIGS. 1 and 3). As the physician continues to hammer the proximal impact surface 128 of the delivery instrument 12, the bone anchor 18 may be driven into the pre-formed hole 9 to a depth desired by the physician. Further, as the bone anchor 18 is driven deeper into the pre-formed hole 9, the legs 24 of the soft tissue anchor 16 may simultaneously be driven into the soft tissue 5.

Upon the bone anchor 18 being seated or prior to being fully seated, the one or more clips 144 (FIG. 4) holding the soft tissue anchor 16 against the clipping portion 136 may be removed. As the physician continues to seat the bone anchor 18 into the pre-formed hole 9 to a depth below an outer surface 15 of the bone 7, the soft tissue 5 becomes clamped with a clamping force 150 against the outer surface 15 of the bone 7 with the soft tissue anchor 16 being forced downward as the bone anchor 18 is impacted downward due to the fixed length of the one or more flexible members 20 (and predetermined length 110 (FIG. 3) of the descending loop portion 106), which results in a fixed distance between the bone anchor 18 and the soft tissue anchor 16. Due to variableness of the thickness of soft tissue 5 that may be encountered, the physician may gauge the clamping force 150 or tightness of the soft tissue 5 against the bone 7 by continuing to drive the bone anchor 18 into the bone until the soft tissue 5 is clamped against the bone 7 with an appropriate clamping force. In this manner, the repair device system 14 may be employed with various thicknesses of soft tissue 5.

Further, the repair device system 14 provides advantages for physicians by eliminating complex suture patterns necessitated for threading and cinching the soft tissue against bone and implanted bone anchors, whereas the repair device system 14 of the present invention, upon appropriately seating the bone anchor 18 in the bone 7, the soft tissue 5 simultaneously becomes fixated to the bone with the soft tissue anchor 16. Further, the repair device system 14 minimizes potential issues by being implantable in a centralized manner without tangential components and sutures being coupled at non-centralized locations, thereby eliminating complexity and potential irritation due to multiple non-centralized components.

Further, with reference to FIGS. 3 and 6, the coupling of the second flexible member 100 to the first flexible member 98 facilitates multiple attachment points adjacent the inner periphery 42 of the base 22 of the soft tissue anchor 16, thereby, more effectively distributing the clamping force 150 across the underside surface 40 of the base 22 of the soft tissue anchor 16 against the soft tissue 5. Even further, such distribution of the clamping force 150 by the coupling of the one or more flexible members 20 along multiple attachment points around the protrusions 50 of the base 22 and between the first and second flexible members 98, 100 at the mid portions 102 minimizes the potential for failure of the first and second flexible members 98, 100. Furthermore, upon the soft tissue 5 becoming loaded laterally relative to the axes 46, 72 of the soft tissue anchor 16 and the bone anchor 18, the one or more flexible members 20 at their multiple attachment points adjacent the inner periphery 42 of the soft tissue anchor 16 may substantially minimize potential overloading due to a spring like effect at the attachment points between the first and second flexible members 98, 100 along the mid portions 102, thereby, minimizing potential failure at the repair site and minimizing potential lateral tearing of the legs 24 through the soft tissue 5. Also, during the healing process and thereafter, upon the soft tissue 5 becoming loaded by activity of the patient, the cooperation between the clamping force 150 of the soft tissue anchor 16 and the multiple legs 24 being seated within the soft tissue 5 may substantially prevent lateral movement of the soft tissue 5 relative to the bone 7, thereby, maintaining the soft tissue 5 to become properly fixated to the bone 7 and minimize failure and the potential for follow-up procedures. Also, upon fully healing, the only components exposed above the soft tissue may be the upper surface of the soft tissue anchor 16 and portions of the one or more flexible members 20 to provide an implant with a very low exposed profile, thereby, minimizing any potential long term irritation to the patient as well as minimizing potential irritation during the healing process.

Now with reference to FIG. 7, another embodiment of a repair device system 160 is provided. This embodiment of the repair device system 160 may include similar structural characteristics and may be employed in a similar manner as the repair device system 14 of FIG. 3 and described in previous embodiments. This embodiment of the repair device system 160 may include a soft tissue anchor 162 coupled to a bone anchor 164 with one or more flexible members 166. The soft tissue anchor 162 may be similar to the soft tissue anchor of FIG. 2 and may include a base 168 with an upper surface 170 and an underside surface 172 extending between an inner periphery 174 and an outer periphery 176. In this embodiment, the base 168 may also include multiple legs 180, such as eight legs, each extending from the outer periphery 176 with a curvature 182 or radius and extending downward relative to the underside surface 172 of the base 168. Further, in this embodiment, the outer periphery 176 may not define the protrusions 50 depicted in FIG. 2 such that coupling structure may be the base 168 and portions of the legs 180. The bone anchor 164 may include similar structure of the bone anchor 18 described and depicted in FIG. 3, but in this embodiment, the bone anchor 164 may define an aperture 184 extending through an intermediate portion 186 of the bone anchor 164 such that the aperture 184 may extend to opposing sides 188 of the bone anchor 164.

Further, in this embodiment, the one or more flexible members 166 may extend with a single flexible member 190. Such single flexible member 190 may extend as a continuous loop or closed loop or may extend with two free ends. The single flexible member 190 may be one or more flexible filaments that may be woven together to form the single flexible member 190. The single flexible member 190 may be coupled to the base 168 and coupled against portions of the legs 180 of the soft tissue anchor 162. Further, the single flexible member 190 may extend from the base 168 and through a central opening 192 defined by the inner periphery 174 of the soft tissue anchor 162 so as to extend with a downward descending portion 194 to extend through the aperture 184 defined in the bone anchor 164. In this manner, the single flexible member 190 may be coupled to the bone anchor 164 and the soft tissue anchor 162. With this arrangement, the repair device system 160 may be coupled to bone and soft tissue for fixating the soft tissue to bone, similar to the repair device system 14 described and depicted in FIGS. 5 and 6.

Now with reference to FIG. 8, another embodiment of a repair device system 200 that may be employed for fixating soft tissue to bone. This embodiment of the repair device system 200 may function similarly and include similar structure to the repair device systems depicted in previous embodiments. For example, the repair device system 200 may include a soft tissue anchor 202 interconnected to a bone anchor 204 with one or more flexible members 206. As in previous embodiments, the repair device system 200 may be employed with, for example, the delivery instrument 12 of FIG. 5 and may be employed for coupling soft tissue to bone in a similar manner and with similar functionality as depicted and described in FIGS. 5 and 6 herein. Further, as will be apparent to one of ordinary skill in the art, the repair device system 200 of this embodiment may be employed with the delivery instrument 250, as depicted in FIG. 12, such that the repair device 200 and delivery instrument 250 may be employed with similar functionality for fixating soft tissue to bone as that described and depicted in FIGS. 5 and 6.

With reference to FIGS. 8 and 9, the soft tissue anchor 202 may include a base 208 and multiple legs 210 that each may extend downward or in a substantially similar or common direction from the base 208. As in previous embodiments, the base 208 may exhibit a generally circular profile. The base 208 may exhibit a washer structure with the legs 210 or anchoring structure extending therefrom. The base 208 may include an upper surface 212 and an underside surface 214 each extending to and defining an outer periphery 216 and an inner periphery 218. The inner periphery 218 may define a central opening 220 or circular opening that may be symmetrically defined in the base 208. The legs 210 may extend directly from the outer periphery 216 such that the legs 210 may exhibit a bend or curve and then extend away from the underside surface 214. In one embodiment, the legs 210 may be elongated and extend generally perpendicular relative to the underside surface 214 of the base 208 along a majority of the elongated length of the legs. The legs 210 may extend to a distal end or free end 222 and may be sized and configured to sink into and engage with soft tissue. In one embodiment, the legs 210 may maintain a fixed configuration (pre-delivery and post-delivery into soft tissue) that may extend generally linearly, but for the above-described bend or curved portion of the legs 210 adjacent to the outer periphery 216 of the base 208. In one embodiment, similar to previous embodiments, the free end 222 or free end portion of the legs 210 may exhibit a straight edge profile (side view) and may also exhibit a point profile (front view). In another embodiment, each of the legs 210 may extend a similar length. The legs 210 of the soft tissue anchor 202 may be a length 224 sized and configured to extend with a partial depth into soft tissue, and not fully through the soft tissue. In one embodiment, the soft tissue anchor 202 may include six legs 210 or more, such as eight legs. In another embodiment, the soft tissue anchor 202 may include four legs, or at least four legs 210. In another embodiment, the soft tissue anchor 202 may include at least three legs 210.

Further, in another embodiment, the base 208 and legs 210 of the soft tissue anchor 202 may act as coupling structure for the flexible member 206. For example, the flexible member 206 may be coupled to two adjacent legs 210 as well as portions of the base 208, similar to that described and depicted in the embodiment of FIG. 7 and discussed in further detail herein. As such, in this embodiment, the outer periphery 216 of the base 208 of the soft tissue anchor 202 may extend with a circular profile, but for the legs 210, so as to not exhibit the protrusions as described in previous embodiments. With this arrangement, the flexible member 206 can effectively couple the soft tissue anchor 202 to the bone anchor 204.

With reference to FIGS. 8, 10 and 11, the bone anchor 204 of the repair device system 200 will now be described. The bone anchor 204, similar to previous embodiments, may be an elongated structure extending between a proximal end 226 and a distal end 228 and defining a bone anchor axis 230 along a longitudinal length 232 of the bone anchor 204. Further, the bone anchor 204 may extend laterally with a circular profile (see FIG. 11) and may define ribs 234 extending radially along an external surface 236 of the bone anchor 204. Further, similar to previous embodiments, the bone anchor 204 may define a first hole 238 and a second hole 240 within the bone anchor 204. The first hole 238 may extend longitudinally along the bone anchor axis 230 and be defined in the surface along the proximal end 226 of the bone anchor 204. The second hole 240 may extend laterally relative to the bone anchor axis 230 and may extend between opposing sides of the bone anchor 204 adjacent the distal end 228 of the bone anchor 204 or at a location closer to the distal end 228 than the proximal end 226 of the bone anchor 204.

Regarding FIGS. 10, 11A and 11B, the bone anchor 204 may include a flattened portion 242 or flattened side surface (see FIG. 11). Such flattened portion 242 may extend along opposing sides of the bone anchor so as to be at least partially defined in the ribs 234 along the external surface 236 of the bone anchor 204. Such flattened portion 242 may extend from the lateral second hole 240 to the proximal end 226 of the bone anchor 204. With such flattened portion 242, the flexible member 206 (FIG. 8) may extend through the lateral second hole 240 and extend upward along the opposing flattened portions 242 toward the soft tissue anchor 202 (see FIG. 8). With this arrangement, the ribs 234 may extend radially over the external surface 236 of the bone anchor 204 in a discontinuous manner so as to be separate and discrete relative to other ribs 234. Further, the external surface 236 of the bone anchor 204 may exhibit structure along a distal portion 244 of the bone anchor 204 to assist the bone anchor 204 to maintain proper orientation and alignment as the bone anchor 204 is implanted into bone. For example, the distal portion 244 of the bone anchor 204 may extend distally from the second hole 240 with a cylindrical surface 246 which may transition distally to a conical surface 248 so as to taper toward the distal end 228 of the bone anchor 204.

Further, as previously set forth, the bone anchor 204 may define the first and second holes 238, 240. The first hole 238 may be sized and configured to receive an engagement portion 252 of a delivery instrument 250 (see FIG. 13A) at the proximal end 226 of the bone anchor 204. The first hole 238 may extend within the bone anchor 204 in a deeper manner than depicted in previous embodiments so that the first hole 238 extends beyond a majority of the elongated length 232 of the bone anchor 204. As such, the first hole 238 may be sized to ensure appropriate engagement and to maintain alignment with the engagement portion 252 of the delivery instrument 250. The second hole 240 may extend laterally through and between opposing sides of the bone anchor 204 adjacent a lower end of the opposing flattened portions 242 of the bone anchor 204. Further, the second hole 240 may extend through the bone anchor 204 so as to extend symmetrically through the bone anchor axis 230. The second hole 240 may exhibit an oval profile, as shown in FIG. 11B, sized and configured to receive and hold the flexible member 206 (FIG. 8). In this manner, portions of the flexible member 206 may extend through the second hole in a side-by-side arrangement.

Now with reference to FIGS. 8, 12, 13 and 13A, the repair device system 200 may be removably coupled to a delivery instrument 250, similar to previous embodiments. As in previous embodiments, the soft tissue anchor 202 may be maintained in a coupled arrangement to the bone anchor 204 with one or more flexible members 206 and, as depicted in this embodiment, a single flexible member 206. For example, the flexible member 206 may extend through the laterally extending second hole 240 defined in the bone anchor 204 so that two opposing end loops 256 of the flexible member 206 may extend proximally along the opposing flattened portions 242 of the bone anchor 204. The end loops 256 may then be positioned through the central opening 220 of the soft tissue anchor 202 so that each end portion of the two end loops 256 may wrap around, for example, two adjacent legs 210 and portions of the base 208 of the soft tissue anchor 202. In this manner, the soft tissue anchor 202 may be coupled to the bone anchor 204 to form the repair device system 200.

Further, the repair device system 200 may be employed to fixate soft tissue to bone with the delivery instrument 250, similar to previous embodiments. For example, in this embodiment, the delivery instrument 250 may include a handle 258 and a shaft 260, the delivery instrument 250 defining a delivery instrument axis 262 extending longitudinally therein. The handle 258 may define a proximal end surface that may act as a proximal impacting surface 264 (for impacting with a hammer), similar to previous embodiments. The shaft 260 may be fixedly coupled to the handle 258 and may longitudinally extend distally to a distal end portion 266. The distal end portion 266 may include an alignment portion 268, an engagement portion 252, and a distal impacting surface 272. The alignment portion 268 may be sized and configured to be positioned through the central opening 220 of the soft tissue anchor 202. The engagement portion 252 may be sized and configured to be inserted through the first hole 238 defined in the proximal end 226 of the bone anchor 204 so that the distal impacting surface 272 of the delivery instrument 250 abuts with the proximal end 226 or proximal surface of the bone anchor 204. With this arrangement, the delivery instrument axis 262 may be coaxial with the bone anchor axis 230.

In this embodiment, the repair device system 200 may be removably coupled to the delivery instrument 250 with a retainer element 274. With the distal end portion 266 of the delivery instrument 250 engaged with the bone anchor 204, as previously set forth, the retainer element 274 may be sized and configured to hold and suspend the soft tissue anchor 202 along the distal end portion 266 of the shaft 260 so that the flexible member 206 is taut or in a taut position. In this taut position, the soft tissue anchor 202 may be retained at and spaced a predetermined distance from the bone anchor 204 so as to be suspended above the bone anchor 204. The retainer element 274 may include a line 276 and a tab 278. As depicted in FIG. 13A, the line 276 may extend along the underside surface 214 of the base 208 of the soft tissue anchor 202 and extend upward on both sides of the base 208 to the tab 278. The tab 278 may define channels 280 therein or coupling structure for holding portions of the line 276. The tab 278 may also be sized to couple to the shaft 260 of the delivery instrument 250 with, for example, an interference fit or the like such that the line can be wrapped around the shaft 260 so as to assist in the interference fit. In this manner, the retainer element 274 may maintain the flexible member 206 in a taut position so as to temporarily and removably hold or couple the repair device system 200 to the delivery instrument 250 and, upon fixating soft tissue to bone with the repair device system 200, the line 276 may be removed by, for example, being snipped and then pulled from under the soft tissue anchor 202. In another embodiment, the tab 278 of the retainer element 274 may be removed from the shaft 260 to facilitate releasing the wrapped line 276 held between the tab 278 and the shaft 260 to, thereby, release the delivery instrument 250 from the repair device system 200.

The various repair device and system embodiments or other embodiments disclosed herein may be applied to any one of various soft tissue to bone repairs. For example, the various repair device embodiments may be employed for flexor tendon repairs, patellar tendon repairs, Achilles tendon repairs, quadriceps tendon repairs, and/or bicep tendon repairs, or any other tendon/ligament to bone repairs, such as kidner procedures or insertional Achilles repairs, or any other tendon/ligament to bone repairs. As such, the repair device may be appropriately sized for proper fixation to the different sizes or types of soft tissue and bone.

While the invention may be susceptible to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and have been described in detail herein. Further, the structural features of any one embodiment disclosed herein may be combined or replaced by any one of the structural features of another embodiment set forth herein. As such, it should be understood that the invention is not intended to be limited to the particular forms disclosed. Rather, the invention includes employing any portion of one embodiment with another embodiment, all modifications, equivalents, and alternatives, falling within the spirit and scope of the invention as defined by the following appended claims. 

What is claimed is:
 1. A repair device system for fixating soft tissue to bone, the repair device system comprising: a bone anchor having an elongated structure extending between a proximal end and a distal end, the bone anchor defining a bone anchor axis extending along the elongated structure; a soft tissue anchor having a base with multiple legs extending from the base so as to extend toward the bone anchor; and one or more flexible members extending to couple the soft tissue anchor to the bone anchor, the one or more flexible members being sized and configured to substantially maintain the soft tissue anchor to be spaced relative to the bone anchor at a pre-determined distance.
 2. The repair device system of claim 1, wherein, as the bone anchor is seated into bone, the one or more flexible members facilitate the soft tissue anchor to simultaneously fixate the soft tissue against the bone.
 3. The repair device system of claim 1, wherein the base defines a central opening extending centrally through the base, the soft tissue anchor defining a tissue anchor axis extending axially relative to the central opening of the base, the tissue anchor axis configured to extend substantially co-axial with the bone anchor axis.
 4. The repair device system of claim 1, wherein the base of the anchor extends with an upper surface and an underside surface to define an outer periphery therebetween, the legs extending directly from the outer periphery and extending with a bend so that the legs are configured to extend toward the bone anchor.
 5. The repair device system of claim 1, wherein the one or more flexible members extends with a continuous loop.
 6. The repair device system of claim 1, wherein the one or more flexible members comprises two loop portions extending upward from the bone anchor to wrap around portions of the soft tissue anchor.
 7. A method of fixating soft tissue to bone, the method comprising: providing a bone anchor coupled to a soft tissue anchor with one or more flexible members such that the bone anchor is engaged with a distal impacting surface of a delivery instrument with the soft tissue anchor positioned proximally along the delivery instrument with the one or more flexible members extending along the delivery instrument between the bone anchor and soft tissue anchor; positioning a distal end of the bone anchor adjacent the soft tissue and adjacent a pre-formed hole defined in the bone with the soft tissue positioned over the bone; and applying a force to the bone anchor with the delivery instrument to drive the bone anchor through the soft tissue and into the pre-formed hole such that, upon the bone anchor being driven into the pre-formed hole, the one or more flexible members pull legs extending from a base of the soft tissue anchor into the soft tissue such that an underside of the base is positioned against an outer surface of the soft tissue to substantially fixate the soft tissue against the bone.
 8. The method according to claim 7, wherein the applying comprises driving the bone anchor into the pre-formed hole to substantially simultaneously couple the soft tissue anchor to the soft tissue.
 9. The method according to claim 7, wherein the applying comprises pulling the legs of the soft tissue anchor into the soft tissue with the one or more flexible members coupled to the bone anchor so that the soft tissue anchor clamps down upon the soft tissue as the bone anchor is seated within the pre-formed hole.
 10. The method according to claim 7, wherein the applying comprises maintaining a substantially fixed distance between the bone anchor and the soft tissue anchor with the one or more flexible members.
 11. The method according to claim 7, wherein the applying comprises pounding a proximal end of the delivery instrument so that the distal impacting surface of the delivery instrument pounds the bone anchor into the pre-formed hole of the bone.
 12. The method according to claim 7, wherein the providing comprises providing a retainer element for removably coupling the bone anchor to the delivery instrument, the retainer element having a line extending along an underside of the soft tissue anchor so that the one or more flexible members maintain a taut position. 